Plain English Summary
Background and study aims
The testes are housed in the scrotum because the scrotum is a few degrees cooler than the core body temperature, which forms the best environment for sperm production. This study aims to find out whether exposing the scrotum to lower temperatures using a cooling patch improves the fertility of men who have abnormal sperm counts.
Who can participate?
Any man above the age of 18 who has an abnormal sperm count.
What does the study involve?
Participants are randomly allocated to one of two groups. Men in one group wear the cooling patch for 8 hours per day for a period of 90 consecutive days. Men in the other group do not wear the patch. In order to determine if there is an improvement we test the participants’ sperm count at the start and the end of the study.
What are the possible benefits and risks of participating?
To date we do not know of any risks as the cooling patch has been tested and proven to be safe.
Where is the study run from?
Nottingham University Hospitals (UK).
When is the study starting and how long is it expected to run for?
August 2011 to May 2012.
Who is funding the study?
University of Nottingham (UK).
Who is the main contact?
Mr William Atiomo (william.atiomo@nottingham.ac.uk)
Dr Ilias Nikolopoulos (illias.nikolopolous@nuh.nhs.uk)
Dr Waseem Osman (Mohammed.Osman@nuh.nhs.uk)
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EM 11024
Study information
Scientific title
A pilot randomised study of the effects of the FertilMate - a scrotal cooling patch on male fertility
Acronym
SCOP
Study hypothesis
To determine whether exposing the scrotum to lower temperatures by means of a scrotal cooling patch may improve fertility
Ethics approval
NRES Committee East Midlands - Nottingham 2, 27/05/2011, ref: 11/EM/0163
Study design
Randomised control trial pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Reproductive Medicine
Intervention
1. Scrotal cooling patch worn by the study group
2. Semen analyses on all 40 participants on day 0 and day 90
3. Serum Metabolomics tested by means of 1x 20ml blood sample
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. To determine whether exposing the scrotum to lower temperatures by means of a scrotal cooling patch may improve fertility
2. The main parameter will be a change to sperm count, quality and concentration
3. Improvements to sperm motility and morphology
Secondary outcome measures
Scrotal bloodflow
Overall trial start date
01/08/2011
Overall trial end date
01/05/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Males
2. Aged 18 to 45 years of age
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
40, 20 in the study group and 20 in the control group
Participant exclusion criteria
1. Candidates who have undergone a vasectomy
2. Candidates who have an allergy to menthol
3. Males aged below 18 and older than 45 years on age
4. We will not be recruiting individuals that are unable to consent for themselves and nor will we be including participants who are from vulnerable groups
Recruitment start date
01/08/2011
Recruitment end date
01/05/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nottingham University Hospitals
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
c/o Mr Paul Cartledge
University of Nottingham
University Park
Nottingham
NG7 2 RD
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Nottingham (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22540417
Publication citations
-
Protocol
Osman MW, Nikolopoulos L, Haoula Z, Kannamannadiar J, Atiomo W, A study of the effect of the FertilMate™ Scrotum Cooling Patch on male fertility. SCOP trial (scrotal cooling patch) - study protocol for a randomised controlled trial., Trials, 2012, 13, 47, doi: 10.1186/1745-6215-13-47.